CN101507759A

CN101507759A - Traditional Chinese medicine combination capable of preventing and treating seborrheic dermatitis and preparation and preparation method thereof

Info

Publication number: CN101507759A
Application number: CNA2009100810351A
Authority: CN
Inventors: 付蓉
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-03-31
Filing date: 2009-03-31
Publication date: 2009-08-19
Anticipated expiration: 2029-03-31
Also published as: CN101507759B

Abstract

The invention relates to a Chinese medicinal composition for preventing and treating seborrheic dermatitis, which comprises the following raw medicines in portion by weight: 20 to 50 weight portions of pseudolarix, 25 to 45 weight portions of kuh-seng, 10 to 20 weight portions of clove, 10 to 20 weight portions of cinnamon, and 30 to 60 weight portions of Cacumen Platycladi. According to clinical observation and experimental verification, the Chinese medicinal composition can effectively prevent and treat the seborrheic dermatitis. After two weeks treatment, symptoms such as erythema, pruritus and scale are improved markedly, and statistical analysis shows that the total effective rate of the tested medicament is 75.24 percent and the total effective rate of the contrasted medicament (Caile lotion, Xian Yangsen Pharmaceutical Ltd.) is 58.10 percent; and after four weeks treatment, the total effective rate of the tested medicament is 85.71 percent, and the total effective rate of the contrasted medicament is 65.71 percent, so that the treatment effect of the tested medicament is obviously higher than that of the contrasted medicament. The relapse rate of the seborrheic dermatitis is only 1.9 percent within one month after the medicament of the invention is stopped, and is low compared with 5.7 percent of the relapse rate of the contrasted medicament; and no allergic symptom occurs during the observation period, so that the medicament has high safety. The Chinese medicinal composition has good application prospect.

Description

The Chinese medicine composition of prevention and treatment seborrheic dermatitis, preparation and preparation method thereof

Technical field

The present invention relates to a kind of Chinese medicine composition, specifically a kind of Chinese medicine composition that can effectively play prevention and treatment seborrheic dermatitis, and, belong to the Chinese materia medica field by external preparation of said composition preparation and preparation method thereof.

Background technology

One, about seborrheic dermatitis and harm thereof

(Seborrheic Dermatitis is a kind of common chronic pimple squama inflammatory skin disease SD) to seborrheic dermatitis, often involves the abundant skin part of sebaceous gland such as scalp, neck surface and trunk top.Primary disease crowd's sickness rate is 1%～3%, and young people is 3%～5%, and the male is more than the women.In the patient of AIDS relevant disease, the primary disease sickness rate is then up to 32%～83%.Primary disease is sent out the patient in nervous system disease well in addition, as mental disorder, parkinson disease, cerebrovascular accident, epilepsy, nervus centralis wound, facial paralysis, syringomyelia, quadriplegia and the person that takes the antipsychotic drug; And the obesity that endocrinopathy causes, alcoholic are also easily suffered from primary disease.The primary disease pathogeny is still very not clear and definite, but discovering in recent years, closer related of pungent rich product of infected by microbes such as endocrine disturbance, dysimmunity, Nervous and Mental Factors, environmental factors (being mainly the use of central air-conditioning), acarid and diet etc. and having of primary disease.At present often slight brawny tetter dermatitis is called the pityriasis simplex capitis or the dandruff clinically, can only shows as increasing of the simple dandruff; Severe patient shows as greasy scales map shape patch, can be with alopecia, ooze out and thick crust, and the seborrhea position all can take place, and the patient understands conscious pruritus.Aspect General Symptoms, because the pruritus that scalp causes, the patient is easy to generate agitation, has difficulty in going to sleep etc.

Because seborrheic dermatitis is because of skin greasing erythema occurs, is covered with squama, thereby the traditional Chinese medical science is named as " seborrhea ichthyosis " or " seborrheic dermatitis " with this disease." the 84 piece of Waike Zhengzong, Orthodox Manual of External Diseases seborrhea ichthyosis " pointed out: " seborrhea ichthyosis is born in head, face, ear, item more, send out, the initial stage little itching, then gradually give birth to white scales for a long time, folded flying up taken off and given birth to ".And " Yizong Jinjian surgery heart method gist " also put down in writing: " seborrhea ichthyosis is born on the face, the order edema of just leavening dough, the nymph that itches row, scaly dry skin, the time play white scales, grab the back utmost point and itch, scratch, the wet Sheng person of heat soaks yellow fluid; Wind-dryness Sheng person Tianjin blood, the pain embarrassment ".Seborrhea ichthyosis is from the beginning of in the hair, to positions such as downward and appearance, ear, neck, axillary fossa, chest, omoplate portions.Seborrhea ichthyosis has dryness and moist branch usually.Dryness is sent out in the scalp person, and visible head fills the air, the dry white scales of pityrosporum sample comes off uniformly, and conscious itching very comes off when scratching more very, scratches and more feels difficult the ending that very itch, and white scales falls and be living, with the passing of time often comes off with hair is sparse.Moist person is slightly yellowy erythema or light red speckle, not of uniform size, clear border and the edge is irregular, greasy scales is thick long-pending on it, form crust, sometimes can be with rotten to the corn, sepage, the full scalp of severe patient portion all is covered with greasy filth squama and crust, with the passing of time also often come off with hair is sparse, very person's eyebrow is also tear-away.

Two, the cause of disease of seborrheic dermatitis and pathogeny

Though it is generally acknowledged the morbidity of seborrheic dermatitis is the result of numerous combined factors effects, the sebum secretion due to increasing as inherited genetic factors, androgen is hyperfunction, infective agent, immunodeficiency etc.But more and more study evidence and show that the morbidity of seborrheic dermatitis is relevant with pityrosporum horse salad bacterium.

Chlosma (Malassezia) is the resident flora on human and the homoiothermic animal skin for having a liking for fat Basidiomycetes yeast, almost all can turn out on all adult skins.It mainly is grown in the human skin horny layer, and is relevant with triglyceride, free fatty, sebaceous gland that skin surface exists, and its density reduces with the minimizing of age growth because of lipide component.Relevant research is verified, and the chlosma of human body skin parasitism derives from the external world, and increases parasitic increase in density with the age.Under the influence of some predisposing factor, it and tinea versicolor, chlosma folliculitis, seborrheic dermatitis, atopic dermatitis and some psoriatic morbidities are closely related.Because it has the fat of having a liking for, so the normal skin shallow-layer horny layer of invading causes mycotic infection of superficial part.Discover that this disease can obviously be alleviated its symptom under double blinding antifungal drug therapeutical effect, thereby proved that also chlosma is the principal element that causes seborrheic dermatitis.Chlosma mainly is divided into 7 kinds, and wherein Malassezia furfur (Malassezia furfur) is the main bacteria seed that causes seborrheic dermatitis, and its spore shape changes greatly, can grow mycelia.According to the difference of its yeast form, be divided into circle, oval, oval pityrosporum furfur again.In vivo and in vitro under the different situation of nutritional condition, show as yeast mutually or the mycelia phase, its growth has strict lipid demand.Because sebum secretion increases, for the chlosma that exists in the skin provides abundant source of nutrition and proliferation conditions, the metabolite of chlosma stimulates triglyceride to discharge free fatty, consumes satisfied fatty acid, leave over unsaturated fatty acid, thereby cause the generation of scytitis.

Three, seborrheic dermatitis treatment As-Is analysis

Though modern medicine is furtherd investigate the cause of disease and the pathogenesis of seborrheic dermatitis, and on Therapeutic Method, obtained remarkable progress, but because the primary disease pathogeny is still very not clear and definite, thereby so far, seborrheic dermatitis does not all also find comparatively effectively Therapeutic Method and medicine clinically.Therefore, main still with degrease on Therapeutic Method and medicine except traditional dietary adjustments and anti symptom treatment, sterilization, antiinflammatory, antipruritic is main.

(1) doctor trained in Western medicine aspect

Antifungal drug treatment: (1) ketoconazole (Ketoconazole, KCZ): be the artificial synthetic imidazoles dioxane derivative of Belgian Yang Sen company in 1976, it is the spectrum antifungal drug, be widely used in clinical treatment superficial part and deep mycosis in 1978, nineteen eighty-two finds that it is effective to capitis pityriasis and seborrheic dermatitis, and external or oral medication are all succeeded.In the imidazoles antifungal agent, ketoconazole is the strongest to the pityrosporum furfur bacteriostatic activity, and has bactericidal activity, is the medicine of effective anti-pityrosporum furfur.Proved that with in vitro tests KCZ has good effectiveness to avette pityrosporum furfur in the body, nineteen ninety U.S. FDA official approval 2% TPIATOP treatment brawny tetter dermatitis.The nineties, more domestic mechanisms and expert had once carried out phase ii clinical trial with regard to 2% ketoconazole (adopting pleasure, Xi'an Yang Sen company) lotion, and the result who is drawn is that 2% ketoconazole (adopting pleasure, Xi'an Yang Sen company) lotion has curative effect preferably to seborrheic dermatitis.Its mechanism of action is by competitive inhibition fungus lanosterol 14a-demethylase, synthesizing of interference cell film ergosterol, cause ergosterol to be exhausted, make many enzyme activity changes on film integrality, permeability and the film, the endochylema content oozes out and a bacteriostasis.With the scalp keratin high affinity is arranged after the ketoconazole external, local concentration height, its antifungic action of sustainable performance.Feeling sick can appear in oral ketoconazole, dizzy and abnormal liver function, even can cause the side effect of gynaecomastia and inhibition adrenal cortex function, clinical less usefulness.(2) terbinafine: terbinafine (terbinafine) is a kind of propylene amine broad-spectrum antifungal medicine, by suppressing the zamene Cycloxygenase in fungal cell's ergosterol building-up process, and zamene is accumulated cause ergosterol to be exhausted in cell, human cell membrane structural deterioration and play bactericidal action.Shortcoming is that price is expensive.(3) itraconazole: to outbreak or topical therapeutic nonresponder can oral itraconazoles (Itraconazole) repeatedly, it has stronger antibacterial activity, the quantity that can effectively suppress fungus is a kind of synthetic dioxolanes triazole type medicine, belongs to the broad-spectrum antifungal medicine.Its mechanism of action is identical with other azole drug, itraconazole has disturbed the activity of cytochrome P-450 dependent enzyme, 14 α-demethyl enzyme, cause the 14 α-accumulation of demethyl enzyme and the minimizing of ergosterol among the fungal cell, thereby changed the cell function that many films participate in, thereby suppressed the infection of scalp fungus.Because seborrheic dermatitis is a kind of chronic disease and position limitation, be not suitable for oral antifungal drug treatment.(4) ciclopirox olamine frost, 0.77% ciclopirox gel: paste medicine is when being applied to the brawny tetter dermatitis, and is also inconvenient on usage.(5) 4% resorcin shampoos, vancide ZP hair washing agent, selenium sulfide hair washing agent: clinical efficacy is very dissatisfied, and is prone to the exsiccant side effect of hair, and relapse rate is higher.

The anti-inflammatory drug treatment: common medicine has 1% hydrocortisone frost etc., can reduce partial inflammatory reaction, thereby alleviate clinical symptoms.But this type of preparation of life-time service can cause corticosteroid dermatitis and rebound phenomenon, produces many side effect such as drug dependence dermatitis, atrophy of epidermis, pigmentation, and therapeutic effect is not obvious.In addition, external medication brawny tetter dermatitis such as corticosteroid hormone because scalp has hair to exist, and the position is special, and external-application cream, ointment, liquid are all not too convenient, have influenced the carrying out of treatment usually to a certain extent.

Immunosuppressant or immunomodulator: neotype immunosuppressant such as tacrolimus, a Mei Kemosi.Tacrolimus is a kind of ascomycin derivative, but suppressor T cell propagation suppresses the generation of IL-2, IFN-γ and TNF-α, and topical application can suppress delayed allergy; Mei Kemosi belongs to the plain derivant of ascus, but suppressor T cell activation and discharge cytokine, and in vitro tests demonstrates the active and stronger anti-inflammatory activity of certain anti-Malassezia furfur and oval pityrosporum furfur, and does not have the side effect of glucocorticoid sample.Studies show that the side effect of local Burning Pain sense can appear in immunosuppressant, and price is expensive at present, clinical expansion acquires a certain degree of difficulty.

Tretinoin: as 0.1% tretinoin cream, WEIANZHI JIAONANG, isotretinoin soft gelatin capsule.For oral administration have a reduction sebum excretion rate, regulates the effect of affected skin immunity and inflammatory reaction, but the serious adverse reaction of developmental disorder can occur; External is by reducing smegma, reduce surperficial free fatty and reach the effect of treatment seborrheic dermatitis, but patient is prone to local red and swollen, desquamation, conscious burning sensation in various degree in use.

(2) traditional Chinese medical science aspect

The internal treatment mainly is the main formula plus-minus with the XIAOFENG SAN, controls based on dispelling wind, is aided with the spleen invigorating removing damp-heat, and nourishing YIN and benefiting blood is moisturized; External treatment lays particular emphasis on heat clearing and damp drying, killing parasites for relieving itching.Chinese medicine is a big treasure-house of China, and people have done more research to the Chinese herbal medicine antifungic action, have affirmed the curative effect of a part of Chinese medicine, and are applied to clinical certain therapeutic effect of having obtained, and have brought into play the characteristic of Chinese medicine fungal infectious disease.But also there are many weak points simultaneously: in the selection of medicine, have certain limitation, promptly selected medicine mostly to be heat-clearing and toxic substances removing dampness class greatly; Institute is water decoction or crude extract with the Chinese medicine majority, therefrom extracts the less for counting of effective ingredient; Large-scale, system, at random, double blinding, multi-center clinical trial is less, mostly only is clinical observation on the therapeutic effect; Not from the experimental study on basis, and directly rise to clinical research, lack the evidence support and the evidence of basic research microcosmic aspect.Even so have very big research space aspect the brawny tetter dermatitis that causes at Chinese medicine external curing chlosma and exploit potentialities.

In sum, good for therapeutic effect at present, there is not recurrence after the drug withdrawal, have no side effect, and preparation method is simple, still there is demand in the medicine of prevention with low cost and treatment seborrheic dermatitis.

Summary of the invention

The objective of the invention is to propose a kind of prevention and the treatment seborrheic dermatitis effective, toxic and side effects is little, the simple Chinese medicine composition of preparation method.

Another object of the present invention is to propose the preparation of above-mentioned prevention and treatment Chinese medicine composition.

A further object of the present invention is to propose the preparation method of above-mentioned Chinese medicine preparation.

The present invention adopts following technical scheme for achieving the above object:

The present invention selects Cortex Pseudolaricis, Radix Sophorae Flavescentis, Flos Caryophylli, Cortex Cinnamomi and Cacumen Platycladi five tastes drug regimen for use, makes each medicine produce synergism these drug regimens, thereby can effectively play the effect of prevention and treatment seborrheic dermatitis.The brief introduction of five tastes medicine medical material is as follows:

Cortex Pseudolaricis: be Pinaceae Pseudolarix plant golden larch Pseudolarix amabilis (Nelson) Rehd.[P.kaempferi Gord.], be used as medicine with root bark and near root bark.Gather after the Beginning of summer root bark and near root bark dry flat folded.The nature and flavor suffering, temperature.Effect with Anti-Puritic and insecticidal.Be used for the trick tinea, neurodermatitis, eczema, leprosy dysentery head.

Radix Sophorae Flavescentis: be the dry root of leguminous plant Radix Sophorae Flavescentis (Sophora flavescens Ait.).The nature and flavor hardship, cold.GUIXIN, liver, stomach, large intestine, urinary bladder channel.Has heat clearing and damp drying, parasite killing, diuretic effect.Be used for hematodiarrhoea, have blood in stool, jaundice urine retention, leucorrhea with red and white discharge, swelling of the vulva pudendal pruritus, eczema, eczema, skin pruritus, scabies leprosy.

Cacumen Platycladi:, be mainly fenchone (fenchone), Camphora, borneol acetate, terpene alcohol in the oil for the branch tip and leaf of Cupressaceae plant Cacumen Platycladi Platycladus orientalis (L.) Franco contains volatile oil; And contain juniperic acid (junipericacid) Quercetin, poplar luteoxanthin (myricetin), kaempferol, hinokiflavone (hinokiflavone), waxiness etc.Nature and flavor are cold, bitter and puckery flavor.Has cooling blood for hemostasis, the effect of growing and blacking hair.

Flos Caryophylli: be Myrtaceae syzygium species plant Flos Caryophylli Eugenia caryophyllata Thunb.[E.aromaticaBaill.; Syzygiumaromatica (L) Merr.et Perry], with alabastrum and its fruit medicine.Alabastrum claims Flos Caryophylli or male Flos Caryophylli, and fruit claims Fructus Caryophylli or female Flos Caryophylli.Begin to be white in color at alabastrum, virescence can be gathered when being cerise at last gradually.The nature and flavor suffering, temperature has the effect of warming middle-JIAO, warming the kidney, sending down the abnormal ascending QI.Cure mainly: singultus, vomiting, regurgitation, dysentery, trusted subordinate's cold type of pain, mass beside the umbilicus, hernia, ringworm.

Cortex Cinnamomi: be the bark of canella Cortex Cinnamomi Cinnamomum cassia Presl.Contain and contain cinnamic aldehyde (cinnamaldehyde), cinnamyl acetate (cinnamyl acetate), eugenol, cinnamic acid, stupid beautiful sour acetic acid, osmanthus diterpene alcohol (cinnzeylanol), acetyl osmanthus diterpene alcohol (cinnzeylanine) in volatile oil, the oil.The big heat of nature and flavor, acrid in the mouth, sweet.It is supporing yang to have the fire of benefit, let the fire back to its origin, dispersing cold for relieving pain, the effect of promoting blood circulation to restore menstrual flow.

Concrete technical scheme of the present invention is:

The Chinese medicine composition of a kind of prevention and treatment seborrheic dermatitis, described Chinese medicine composition is made by following weight parts proportion raw material medicine:

Cortex Pseudolaricis 20～50 weight portions, Radix Sophorae Flavescentis 25～45 weight portions, Flos Caryophylli 10～20 weight portions, Cortex Cinnamomi 10～20 weight portions, Cacumen Platycladi 30～60 weight portions.

The Chinese medicine composition of above-mentioned prevention and treatment seborrheic dermatitis, wherein, the preferred following weight parts proportioning of described Chinese medicine composition:

Cortex Pseudolaricis 30～40 weight portions, Radix Sophorae Flavescentis 35～45 weight portions, Flos Caryophylli 9～14 weight portions, Cortex Cinnamomi 11～16 weight portions, Cacumen Platycladi 40～50 weight portions.

The Chinese medicine preparation of a kind of prevention and treatment seborrheic dermatitis, wherein, described Chinese medicine preparation is made by acceptable auxiliary on above-mentioned Chinese medicine composition and the pharmaceutics.

According to the route of administration difference, Chinese medicine composition of the present invention is made external preparation, as external hair washing preparation, spray, externally used paste and fumigation and wash method preparation.But be not limited to above-mentioned dosage form, can be according to known method in the pharmaceuticals industry, aforementioned pharmaceutical compositions is made various exterior-applied formulation after by the known method degerming.

Preferred dosage form of the present invention is the hair washing preparation, the method for the Chinese medicine preparation of preparation the present invention prevention and treatment seborrheic dermatitis, and its concrete preparation process is:

(1) by the weight portion proportioning weighting raw materials of claim 1 or 2 described each crude drug, standby;

(2) five kinds of crude drug mixing and water addings are decocted three times.Add for the first time the water of 8～12 times of weight, seethed with excitement 2～3 hours; Add for the second time the water of 6～8 times of weight, seethed with excitement 1～2 hour; The water that adds 4～6 times of weight for the third time seethed with excitement 0.5～1 hour; Merge three times decoction liquor, filter, remove wherein impurity;

(3) with filtrate vacuum 1.33Kpa (being 10mmHg), under 40～50 ℃ of environment, be condensed into relative density and be 1.2～1.3 extractum;

(4) utilize spray drying process to make dry extract, promptly make active drug component of the present invention;

(5) the active drug component is added to mixing in the hair washing substrate, promptly makes the hair washing preparation.The w/v of active drug component and hair washing substrate is 6～8:100.

The present invention also can be according to actual needs, make other dosage forms that are fit to the patient, as the seborrheic dermatitis that occurs on other skin outside the scalp can be treated with spray or unguentum.

The external hair washing preparation character that the present invention makes is the sepia thick liquid, and gentle close Chinese medicine fragrance, nonirritant abnormal flavour are arranged.Its usage and consumption are as follows:

(1) after wet the sending out, with this product an amount of (5～10ml) medicines are applied on the scalp of moistening, and the part massage scalp was also crumpled 3-5 minute, stop 10 to 20 minutes, and are clean with clear water then, the next day 1 time, shared 4 weeks.

(2) the alternative shampoo of this medicine uses, and needn't use other hair-washing hair-care articles for use during hair washing.

Advantage of the present invention and benefit:

1. the Chinese medicine composition of prevention of the present invention and treatment seborrheic dermatitis is verified through clinical experiment, can effectively prevent and treat seborrheic dermatitis, and being clearly better promptly appears in symptoms such as patient such as erythema, pruritus, squama after 2 weeks of treatment.

2. statistical analysis shows, during 2 weeks, the total effective rate of test group medicine of the present invention is 75.24% in treatment, and the total effective rate of matched group medicine (adopting happy lotion, Xi'an Yang Sen company) is 58.10%; Treatment is during 4 weeks, the total effective rate of test group medicine of the present invention is 85.71%, and the total effective rate of matched group medicine is 65.71%, though in the clinical observation process, proved two kinds of medicines treatment seborrheic dermatitis all had certain curative effect, the clinical overall symptom of patient also all be improved significantly and alleviate but the matched group medicine that is higher than evident in efficacy of test group medicine of the present invention.

3. statistical analysis shows, during 2 weeks, the chlosma negative conversion rate under the test group drug effect of the present invention is 11.43% in treatment, and the chlosma negative conversion rate under matched group (adopting happy lotion, the Xi'an Yang Sen company) drug effect is 8.57%; Treatment is during 4 weeks, chlosma negative conversion rate under the test group drug effect of the present invention is 61.90%, and matched group (is adopted happy lotion, Xi'an Yang Sen company) the chlosma negative conversion rate under the drug effect is 37.14%, though proved two kinds of medicines in the clinical observation process chlosma is all had certain bacteriostasis, the bacteriostasis of test group medicine of the present invention significantly is better than the matched group medicine.

4. the relapse rate of medicine of the present invention (lotion) after drug withdrawal in 1 month is 1.9%, is lower than the relapse rate of matched group 5.7%.

5. by the statistical result of hematuria routine before and after the treatment, overall health of patients is not produced harmful effect after medicine of the present invention (lotion) Transdermal absorption; And the related reactions that produces in therapeutic process is lighter, does not take other treatment measure, illustrates that the safety of medicine of the present invention is higher.

6. basic drug sensitive test (external drug sensitive test) proves that also the mixed liquor of medicine of the present invention has stronger bacteriostasis, and its minimal inhibitory concentration (MIC value) is less than the minimal inhibitory concentration of each single medicinal material.

7. the scanning electron microscope result shows: medicine of the present invention acts on chlosma respectively after 8 hours, 24 hours, 48 hours, the ultrastructure of chlosma presents the seriality of spore and destroys performance, also further illustrates medicine of the present invention from microcosmic angle chlosma is had antibacterial or germ-resistant effect.

8. according to above-mentioned 1,2,3,4,5,6,7 conclusion analytical proofs, Chinese medicine composition of the present invention has better curative effect for seborrheic dermatitis, and does not have irritated symptom, and safety is higher, therefore has good application prospects and market prospect.

Description of drawings

Fig. 1 physical data is analyzed;

Figure 22 10 routine brawny tetter dermatitis patient occupation scattergrams;

Severity of symptom scattergram when two groups of head of Fig. 3 examine;

Two groups of treatments of Fig. 4 severity of symptom scattergram during 2 weeks;

Two groups of treatments of Fig. 5 severity of symptom scattergram during 4 weeks;

Two groups of drug withdrawals of Fig. 6 are the severity of symptom scattergram during 4 weeks;

Each time point integral mean value of two groups of each symptoms of Fig. 7 changes broken line graph;

The curative effect comparison diagram of two groups of treatments of Fig. 8 each symptom during 2 weeks;

The curative effect comparison diagram of two groups of treatments of Fig. 9 each symptom during 4 weeks;

2 weeks of Figure 10 test group treatment and treatment 4 all curative effect comparison diagrams;

2 weeks of Figure 11 treatment of control group and treatment 4 all curative effect comparison diagrams;

Each time point chlosma microscopy distribution of results figure before and after two groups of treatments of Figure 12;

Figure 13 treats two groups of medicine fungistatic effects of each time point of back comparison diagram;

Figure 14 treats two groups of medicine fungistatic effects of each time point of back variation diagram;

Comprehensive therapeutic effect comparison diagram (one) when 2 weeks of two groups of treatments of Figure 15 and 4 weeks;

Comprehensive therapeutic effect comparison diagram (two) when 2 weeks of two groups of treatments of Figure 16 and 4 weeks;

The MIC average comparison diagram of each single medicinal material of Figure 17 and isoconcentration mixed liquor thereof;

Figure 18 is chlosma spore abundant (* 2000) during without drug effect;

Figure 19 chlosma spore cell wall structures complete (* 5000) during without drug effect;

Figure 20 chlosma spore cell wall structures complete (* 10000) during without drug effect;

Form (* 10000) under the mirror of Figure 21 chlosma during without drug effect;

Figure 22 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 8 hours (* 2000);

Figure 23 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 8 hours (* 5000);

Figure 24 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 8 hours (* 10000);

Figure 25 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 24 hours (* 2000)

Figure 26 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 24 hours (* 5000);

Figure 27 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 24 hours (* 10000);

Figure 28 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 48 hours (* 2000);

Figure 29 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 48 hours (* 5000);

Figure 30 5.5mg/mL Chinese medicine mixed liquor 5 effect chlosmas 48 hours (* 10000).

The specific embodiment

The used medical material of present embodiment meets 2000 editions one ministerial standards of Pharmacopoeia of People's Republic of China all available from China Medicament Group Corp..

The preparation of embodiment 1 medicine hair washing preparation of the present invention

(1) take by weighing each crude drug by following weight portion proportioning:

Cortex Pseudolaricis 20g, Cacumen Platycladi 30g, Radix Sophorae Flavescentis 25g, Flos Caryophylli 10g, Cortex Cinnamomi 12g.

(2) each flavor crude drug mixing and water adding is decocted three times.Add for the first time the water of 8～12 times of weight, seethed with excitement 2～3 hours; Add for the second time the water of 6～8 times of weight, seethed with excitement 1～2 hour; The water that adds 4～6 times of weight for the third time seethed with excitement 0.5～1 hour; Merge three times decoction liquor, filter, remove wherein impurity;

(4) utilize spray drying process extractum to make dry extract, promptly make active drug component of the present invention;

(5) the active drug component that makes is added to mixing in the hair washing substrate, promptly makes the hair washing preparation, (Guangzhou Baiyun District stone well song Liz shape product factory produces its Main Ingredients and Appearance: tie up it and order E, tie up it and order B for active drug component and hair washing substrate ₃, plant keratoprotein, aminoacid silicon fiml, cream; [operative norm] QB/T1974-1994, GDFDA (2002) defend and make up accurate word 29-XK-2307, [production licence] XK16-1085765 number) w/v be 6～8:100.

The preparation of embodiment 2 sprays of the present invention

(1) take by weighing each crude drug by following weight portion proportioning:

Cortex Pseudolaricis 30g, Cacumen Platycladi 60g, Radix Sophorae Flavescentis 40g, Flos Caryophylli 13g, Cortex Cinnamomi 10g.

(4) 70% ethanol is slowly added in the above-mentioned extractum, leave standstill after 18 hours and get supernatant, filter rear filtrate and put the room temperature cooling, after the precipitate with ethanol cooling for the second time, add an amount of distilled water, move to the icebox cooling, after the filtration, it is standby to be prepared into clear paste liquid;

(5) an amount of laurocapram solution (transdermal enhancer) is added in the clear paste liquid, be stirred to and be uniformly dispersed, divide in the spray bottle of packing into.

The preparation of embodiment 3 unguentum of the present invention

Pulverize separately after 79～90 ℃ of oven dry of following raw material medicaments is crossed 30 mesh sieves, take by weighing each crude drug by described weight portion proportioning then, with each crude drug mix homogeneously, make medicine activity component of the present invention at last, this active component and ointment substrate commonly used is mixed, promptly make ointment of the present invention.

Crude drug and consumption: Cortex Pseudolaricis 50g, Cacumen Platycladi 40g, Radix Sophorae Flavescentis 30g, Flos Caryophylli 10g, Cortex Cinnamomi 20g.

The preparation of embodiment 4 cleansing milk of the present invention

(1) take by weighing each crude drug by following weight portion proportioning:

Cortex Pseudolaricis 40g Cacumen Platycladi 50g Radix Sophorae Flavescentis 35g Flos Caryophylli 20g Cortex Cinnamomi 14g

(5) prepare cleansing milk according to a conventional method, component is as follows:

Active drug component 15% of the present invention, hexadeca-octadecyl alcohol 10%, glyceryl monostearate 5%, glycerol 5%, acetylated lanolin 1%, sodium lauryl sulphate 1%, essence 0.2%, antiseptic 0.2%, surplus are water.

The preparation of embodiment 5 body lotions of the present invention

(1) take by weighing each crude drug by following weight portion proportioning:

Cortex Pseudolaricis 45g, Cacumen Platycladi 35g, Radix Sophorae Flavescentis 45g, Flos Caryophylli 12g, Cortex Cinnamomi 15g

(5) above-mentioned active drug component is added in the bath lotion substrate, add thickening agent and essence in right amount and promptly make body lotion preparation of the present invention.

Above-mentioned dosage form be prepared as general knowledge known in this field, the present invention only illustrates at this, the adjuvant of all dosage forms is selected and consumption is not limited thereto, those skilled in the art can do suitably adjustment to it.The present invention is suitable for multiple exterior-applied formulation, differs at this and one enumerates.

Clinical experiment of the present invention and result

One, clinical data

Object of study is chosen in June, 2008 to 2008 year December, at Beijing's front three hospital Dermatology ﹠ STD Dept. (hereinafter to be referred as 220 patients that meet the diagnosis and treatment standard of Jiu Zhening clinical research hospital), be divided into drug test group of the present invention at random and matched group (is adopted happy lotion by table of random number, Xi'an Yang Sen company), every group 110 example.

Two, diagnosis and treatment standard

(1) diagnostic criteria

1. the formulation basis of clinical diagnosis standard

(1) " People's Republic of China's Chinese medicine industry standard-tcm diagnosis criterion of therapeutical effect (issue on June 28th, 1994, implement January 1 nineteen ninety-five) ";

(2) " oral cavity, cutaneous diseases diagnostic criteria " Zhou Changjiang, Qian Xue controls the chief editor, Science Press;

(3) " general family medicine clinical diagnostics " Yin Peida chief editor, Science Press;

(4) " modern skin cypridology " Wu Zhihua chief editor, the Guangdong People's Press;

(5) " clinical dermatology " Zhao distinguishes the chief editor, Jiangsu science tech publishing house.

2. clinical diagnosis standard

(1) Western medicine diagnose standard (clinical symptoms):

(1) slight: the infringement of scalp portion is lamellar canescence pityrosporum shape squama, and substrate is red slightly, and slight pruritus can be accompanied a little alopecia.Skin lesion area＜2 percentage point (2 minutes).

(2) moderate: show as greasy scales map shape patch, the substrate flushing can be with oozing out and thick crust, and pruritus can be accompanied alopecia.2 percentage points of (2 minutes)≤skin lesion area＜4 percentage point (4 minutes).

(3) severe: full head is coated with the greasy scales erythema, ooze out, thick crust, but and frowziness, acute pruritus can be accompanied serious alopecia.4 percentage points of (4 minutes)≤skin lesion area≤6 percentage point (6 minutes).

Lab testing: chlosma microscopy or cultivation are positive.

Annotate: the skin lesion area calculates according to burn surface area, and each percentage point is calculated an integration (1 minute); Palm area of less than calculates according to half integration unit.(scalp portion area accounts for 6% of whole body area, so scalp portion total mark is 6 minutes)

The diagnostic criteria of traditional Chinese medical science disease

(1) wind heat blood dryness syndrome: skin lesion is the pale red patch, drying, desquamation, pruritus, and wind-engaging increases the weight of, or scalp itch, and dandruff is many, and hair is withered to come off; Companion's xerostomia is thirsty, is hard and dry; Body of the tongue is red partially, white and thin fur, thready and rapid pulse.

(2) the intestines and stomach damp-heat syndrome: skin lesion is the flushing patch, and greasy crust bits are arranged, in addition rotten to the corn, ooze out; Companion's bitter taste, mouth is sticking, gastral cavity abdomen feeling of fullness, oliguria with reddish urine, it is smelly dirty to defecate; Red tongue, yellow and greasy fur, slippery and rapid pulse.(2) include standard in

(1) is chosen in the male and female patient that the clinical research hospital outpatient is gone to a doctor at random, age 18-65 year;

(2) meet clinical diagnosis standard (clinical symptoms belongs to moderate, and Chinese medical discrimination belongs to the intestines and stomach damp-heat syndrome);

(3) lab testing identified as positive for Malassezia furfur;

(4) do not use antifungal agent and other medicines (as corticosteroid hormone) in test the last fortnight;

(5) be ready close fit, signature Informed Consent Form person.

(3) exclusion standard

(1) patient of allergic constitution or serious skin allergy;

(2) severe cardiac cerebrovascular, liver, kidney and respiratory system, disease of hematopoietic system, malignant tumor and psychiatric patient are arranged;

(3) scalp merges other skin patient, as following disease Ying Yu and discriminating:

The head psoriasis: the infringement color is scarlet, and the surface is covered with the argenteous squama of multilamellar.Infringement place hair is pencil.Most patient has heavy light phenomenon of summer of winter.Often there is same infringement at other position of health.

Pityriasis rosea: mainly occur in cervical region, trunk and extremity near-end, generally do not invade head.Bigger forerunner's rash is often arranged.The skin lesion ovalize, major axis is consistent with rib or dermatoglyph trend, and squama is carefully thin, is not with greasy.Irrelevant with seborrhea body constitution, often can spontaneous recovery.

Eczema: certain predilection site is arranged.No greasy scales and oiliness crust.Erythra is a pleomorphism, vesicle is often arranged, ooze out, and boundary is often unclear, acute pruritus.Baby's seborrheic dermatitis needs to differentiate mutually with baby's dystopy dermatitis.Latter's predilection site is based on two buccals, the less generation of scalp.

(4) test and used antifungal agent and other medicine (as corticosteroid hormone) in the first two week;

(5) gestation, suckling and the conceived person of possibility are selected;

(6) everyly do not meet above-mentioned other case of including standard in.

Three, safety observation

(1) general health check-up project such as blood, routine urianlysis;

(2) untoward reaction: time, symptom, the degree that itemized record untoward reaction incident occurs, whether pass through special handling and extinction time etc.

Four, the Therapeutic Method and the course of treatment

(1) observes medication

Clinical observation test medication be by clinical research hospital preparation chamber according to weight portion proportioning and preparation technology's requirement that this patent proposed, make specification and be 1000 bottles of the test medications of 100mL/ bottle.Wherein raw material of Chinese medicine Cortex Pseudolaricis, Cacumen Platycladi, Radix Sophorae Flavescentis, Flos Caryophylli, Cortex Cinnamomi are responsible for providing by this Pharmacy department of institute, and hair washing substrate is available from (Baiyun District, Guangzhou City stone well is sung Liz shape product factory in the shampoo in Beijing market sale; Main Ingredients and Appearance: tie up it the life E, tie up it the life B ₃, plant keratoprotein, aminoacid silicon fiml, cream; [operative norm] QB/T1974-1994, GDFDA (2002) defend and make up accurate word 29-XK-2307, [production licence] XK16-1085765 number).

The clinical control medicine: adopt happy lotion (production of Xi'an Janssen Pharmaceutica), wherein contain 2% ketoconazole composition, specification is the 50mL/ bottle.

(2) usage and consumption

Test group: 5～10mL the present invention preparation of having one's hair wash is applied on the hair of moistening, and the part massage scalp was also crumpled 3-5 minute, stopped 10-20 minute, clean with clear water then, the next day 1 time, shared 4 weeks.

Matched group: 5～10mL is adopted on the hair that happy lotion is applied to moistening, and the part massage scalp was also crumpled 3-5 minute, cleans with clear water then, and 2 times weekly, shared 4 weeks.

(3) further consultation and following up a case by regular visits to

When 2 weeks of treatment, 4 weeks, carry out efficacy determination (comprising clinical setting and fungus microscope examination result) respectively.Without any other relevant medicine,, write down untoward reaction simultaneously during the treatment as being recorded in the observation table with other drug.Followed up a case by regular visits to for 4 weeks, observe the recurrence situation.

Five, efficacy evaluation

(1) health giving quality observation

(1) primary symptom situation of change: skin lesion area, erythema, seborrhea degree, pruritus degree, squama degree, and to the sleep, work influence, more than every situation of change.Skin lesion before and after the treatment of same position is taken a picture, contrast its variation.All cases before treatment, 2 weeks of treatment, treatment 4 weeks, drug withdrawal record respectively during 4 weeks.

(2) inferior disease situation of change: General Symptoms and picture of the tongue, pulse condition situation of change, note observing the alopecia situation simultaneously.At least each writes down once before and after the treatment.

(3) chlosma microscopy or cultivation are become feminine gender or are become the positive, feminine gender by strong positive by the positive.

Annotate: chlosma microscopy (40 times of mirrors): feminine gender: every visual field≤1/3; Positive (+): 1/3＜every visual field≤2/3; Positive (++): every visual field〉2/3.

(2) curative effect determinate standard

2. leading indicator curative effect determinate standard

Clinical symptoms: according to the level Four scoring, 0 minute=do not have, 2 minutes=light, 4 minutes=in, 6 minutes=heavy.

Therapeutic evaluation: by recovery from illness, produce effects, improvement, invalid level Four standard rating.

(1) erythema

1) recovery from illness: not red fully; 2) produce effects: grading system reduces by 2 grades;

3) take a turn for the better: grading system reduces by 1 grade; 4) invalid: grading system does not descend or increases the weight of.

(2) squama

1) recovery from illness: complete obiteration; 2) produce effects: grading system reduces by 2 grades;

(3) pruritus

1) recovery from illness: pruritus disappears; 2) produce effects: grading system reduces by 2 grades;

(4) seborrhea

1) recovery from illness: greasy disappearance; 2) produce effects: grading system reduces by 2 grades;

(5) skin lesion area

1) recovery from illness: recover normal skin fully or only leave over pigmentation;

2) produce effects: 100%〉the skin lesion area dwindles 〉=and 70%, grading system reduces by 2 grades;

3) taking a turn for the better: 70%〉skin lesion area dwindles 〉=and 30%, grading system reduces by 1 grade;

4) invalid: the skin lesion area dwindle less than 30% or the scoring no change.

3. comprehensive therapeutic effect criterion

The comprehensive therapeutic effect evaluation is to calculate the curative effect rate with the total mark that each symptom is kept the score, and computing formula (nimodipine method) is: [integration before (integration before the treatment-treatment back integration) ÷ treatment] * 100%.Divide the level Four evaluation:

(1) recovery from illness: skin lesion all disappears, and clinical symptoms obviously alleviates, chlosma microscopy feminine gender, and symptom integral reduces more than 90%;

(2) produce effects: the skin lesion major part disappears, and clinical symptoms obviously alleviates, and the chlosma microscopy is near negative, and symptom integral reduces 60%-89%;

(3) effective: skin lesion partly disappears, and clinical symptoms makes moderate progress, and symptom integral reduces 30%-59%;

(4) invalid: skin lesion disappears not obvious, and clinical symptoms does not alleviate or instead sees deterioration, and symptom integral reduces below 30%.

Six, the experimenter withdraws from experimental condition

(1) some serious disease taking place, must stop interventionalist during the treatment;

(2) anaphylaxis or serious adverse events person are taken place during the medication;

(3) be reluctant to proceed clinical trial in the clinical trial process, propose to withdraw from the claimer.

Seven, pick out and the case that comes off

(1) picks out and the case standard that comes off

(1) pick out the case standard: selected back is found not meet to include standard person in; Serious violation research approach person during the clinical trial.

(2) the case standard that comes off: serious adverse events person is taken place; Run counter to research approach person; Lose visit person; For want of the automatic stopped treatment of curative effect, withdraw from automatically, the person of being studied stops and the observation cycle person that do not finish the scheme defined.

(2) the come off processing of case

(1) serious adverse events person being taken place, need fill in the adverse events table, enters the clinical research interpretation of result;

(2) lose visit person, will take modes such as phone, get in touch with the experimenter as far as possible, the inquiry reason is finished the evaluation item that can finish;

(3) the automatic stopped treatment of curative effect and the observation cycle person that do not finish the scheme defined counts invalid case for want of;

(4) because of the observation cycle person who withdraws from automatically, the scheme defined is not finished in the person's of being studied termination, record withdraws from or ends reason;

(5) run counter to research approach, severe patient is picked out processing, finishes assessment back degradation than the lighter and handles.

Eight, statistical analysis and method

Use the SAS8.2 statistical software observed result and resulting data are carried out statistical procedures: each organizes symptom and sign alleviation degree analyzing, total effective rate analysis, and the effective percentage contrast has no difference of science of statistics etc. between two groups.Measurement data meets normal distribution person is with t check and variance analysis, and homogeneity test of variance is with F check and Levene check, and the person that do not meet the normal distribution is with the non parametric tests of order conversion, and the result is with means standard deviation (X ± S) represent; Enumeration data x ²Check.P＜0.05 thinks relatively have statistical significance.

The clinical experiment result

One, physical data

Collect case complete data person 210 examples between Beijing front three hospital Dermatology ﹠ STD Dept. outpatient service in June, 2008～2008 year December altogether, be divided into two groups at random: test group (drug lotion group of the present invention) and matched group (adopting happy lotion group), every group 105 example, patient's baseline data there are no significant statistically difference has comparability between each group.Concrete condition following (table 1,2,3 reaches shown in Fig. 1,2):

Table 1 physical data analysis (one)

△ x ²Check * T-Test

Statistical analysis:

Through x ²Check, and two groups of patients there are no significant statistically aspect sex, nationality, wedding condition, age, course of disease difference (P〉0.05), have comparability.

Table 2 physical data analysis (two)

Table 3 physical data analysis (three)

Statistical analysis: through x ²Check, two groups of patients are there was no significant difference (P〉0.05) on occupation distributes, and has comparability.

Two, the statistics of brawny tetter dermatitis main clinic symptoms

(1) each organizes the frequency that treatment is preceding, treat 2 weeks, 4 weeks, drug withdrawal 4 grades of orders of severity appearance of each symptom during 4 weeks

The frequency (example) that 4 grades of orders of severity of each symptom occur before and after the table 4 liang group treatment

Shown in the table 4: before two groups of treatments each severity of symptom mainly concentrate on slightly, moderate and severe; Medication concentrates on nothing, slight and moderate after 2 weeks; Medication concentrates on nothing, slight after 4 weeks; Central tendency is identical during 4 weeks with medication substantially after 4 weeks of drug withdrawal.(shown in Fig. 3,4,5,6)

(2) each group is treated preceding, as to treat 2,4 weeks, drug withdrawal each symptom during 4 weeks integration situation

1. the comparison of integration before and after the identical symptom treatment in each group group

The integration comparison of each symptom before and after the treatment of table 5 test group (X ± S)

Variance analysis Dunnett-t check SNK-q compares with treatment is preceding after checking each symptom treatment: * P＜0.05

Statistical analysis:

Through SNK-q check, aspect erythema, seborrhea, pruritus symptom: each time point integration population mean of treatment back all with treat before the symptom integral population mean significant difference is arranged; Treat back 2 all integration population means and treat 4 weeks of back, 8 weeks of drug withdrawal significant difference arranged relatively; Treatment back 4 all integration population means and drug withdrawal 8 all comparing differences are not remarkable.

Through Dunnett-t check and SNK-q check, aspect squama, skin lesion area: each time point integration population mean of treatment back all with treat before the integration population mean significant difference is arranged; Treat back 2 all integration population means and treat 4 weeks of back, 8 weeks of drug withdrawal significant difference arranged relatively; Treatment back 4 all integration population means and drug withdrawal 8 all comparing differences are not remarkable.

The statistical analysis prompting: relatively descend significantly before each symptom integral treatment back of test group and the treatment, demonstrating test group Drug therapy brawny tetter dermatitis has curative effect preferably, and significantly brings into play therapeutical effect in the medication process, can obviously improve related symptoms; Medication 4 during week the remission degree compare remarkable during 2 weeks with medication; Obvious recurrence is not seen in drug withdrawal after 4 weeks, curative effect remains on medication during 4 weeks substantially.(table 5, shown in Figure 7)

The integration of each symptom comparison before and after table 6 treatment of control group (X ± S)

Statistical analysis:

Through Dunnett-t check and SNK-q check, aspect erythema, seborrhea, pruritus, squama, skin lesion area: each time point integration population mean of treatment back all with treat before the integration population mean significant difference is arranged; Comparing difference is not remarkable between each time point integration population mean of treatment back.

The statistical analysis prompting: relatively descend significantly before each symptom integral treatment back of matched group and the treatment, demonstrating matched group Drug therapy brawny tetter dermatitis has curative effect preferably, and acts on obviously in 2 weeks after medication, can significantly improve related symptoms; Continue lasting alleviation of 2 week of medication back symptom, but the alleviation degree is compared with preceding 2 weeks not obvious; Obvious recurrence is not seen in drug withdrawal after 4 weeks, curative effect remains on medication during 4 weeks substantially.(table 6, shown in Figure 7)

2. the comparison of point when same symptoms is same between each group group

The integration comparison of table 7 liang each each symptom of time point of group (X ± S)

Annotate: A represents test group, and B represents matched group; Method: T check and Wilcoxon rank test; Test group and matched group compare: * * P＜0.01

Statistical analysis:

When head examined: through T check, each was organized each main clinic symptoms integral mean value and compares there was no significant difference (P〉0.05).

In 2 whens week of treatment: through the T check, two groups of erythema, pruritus, squama, skin lesion area integral averages are compared there was no significant difference (P〉0.05); Through the Wilcoxon rank test, two groups of seborrhea integral mean values are compared has utmost point significant difference (P＜0.01).

Treatment is during 4 weeks: through the Wilcoxon rank test, two groups of erythema integral mean values relatively have utmost point significant difference (P＜0.01), and two groups of seborrhea integral mean values relatively have utmost point significant difference (P＜0.01); Through the T check, two groups of prurituss, squama, skin lesion area integral averages are compared has utmost point significant difference (P＜0.01).

Drug withdrawal 4 is during week: each organizes each main clinic symptoms integral mean value through Wilcoxon rank test and T check, P all＜0.01, each cardinal symptom of each group has utmost point significant difference in drug withdrawal during 4 weeks.

The statistical analysis prompting: each severity of symptom basically identical before two groups of treatments has comparability; In 2 whens week of treatment, improving aspect the seborrhea symptom, and the test group drug effect significantly is better than the matched group medicine; In 4 whens week of treatment, improving aspect erythema, seborrhea, pruritus, squama, the skin lesion area, and the test group drug effect all significantly is better than the matched group medicine; After 4 weeks of drug withdrawal, the test group medicine still is better than the matched group medicine to the alleviation degree of above symptom.(table 7, shown in Figure 7)

Three, the statistics of brawny tetter dermatitis main clinic symptoms therapeutic evaluation

(1) comparison of treatment main clinic symptoms therapeutic evaluation during 2 weeks

The curative effect of table 8 liang group treatment each symptom during 2 weeks is (example) relatively

Annotate: the # representative does not have this symptom; Cure rate=routine the number of fully recovering/(total routine number-# example number); Cure-remarkable-effectiveness rate=(the routine number of fully recovering+produce effects example number)/(total routine number-# example number); Effective percentage=(the routine number of fully recovering+number+the produce effects example takes a turn for the better routine number)/(total routine number-# example number); Method: x ²Check; Compare with matched group: * * P＜0.01, * P＜0.05, △ P 0.05

Statistical analysis:

Through x ²Check, two groups of medicines are compared at the cure rate aspect above-mentioned each cardinal symptom of treatment and be there is no significant difference (P〉0.05); Two groups of medicines are compared at the cure-remarkable-effectiveness rate aspect treatment erythema, pruritus, the skin lesion area and be there is no significant difference (P〉0.05), the visible significant difference of cure-remarkable-effectiveness rate (P＜0.05) aspect treatment squama symptom, the relatively more visible utmost point significant difference (P＜0.01) of cure-remarkable-effectiveness rate aspect treatment seborrhea symptom; Two groups of medicines are compared at the effective percentage aspect treatment erythema, the squama has significant difference (P＜0.05), relatively has utmost point significant difference (P＜0.01) at the effective percentage aspect treatment seborrhea, pruritus, the skin lesion area.

The statistical analysis prompting: during 2 weeks, the cure rate of two groups of Drug therapys is equal substantially in medication; Two groups cure-remarkable-effectiveness rate is improving erythema, pruritus symptom and is reducing aspect the skin lesion area equally substantially, and aspect treatment seborrhea, squama symptom, the cure-remarkable-effectiveness rate of test group medicine is apparently higher than matched group; Aspect all cardinal symptoms of treatment, the effective percentage of test group Drug therapy is significantly higher than the matched group medicine, and is especially better to the minimizing effect of the improvement of seborrhea, pruritus symptom and skin lesion area.Two groups of Drug therapy brawny tetter dermatitis have been obtained curative effect preferably at medication 2 Zhou Houjun.(table 8, shown in Figure 8)

(2) comparison of treatment main clinic symptoms therapeutic evaluation during 4 weeks

The curative effect of table 9 liang group treatment each symptom during 4 weeks is (example) relatively

Annotate: the # representative does not have this symptom; Cure rate=routine the number of fully recovering/(total routine number-# example number); Cure-remarkable-effectiveness rate=(the routine number of fully recovering+produce effects example number)/(total routine number-# example number); Effective percentage=(the routine number of fully recovering+number+the produce effects example takes a turn for the better routine number)/(total routine number-# example number); Method: x ²Check; Compare with matched group: * * P＜0.01, * P＜0.05

Statistical analysis:

Through x ²Check, two groups of medicines are compared visible significant difference (P＜0.05) at the cure rate aspect the treatment squama, relatively have utmost point significant difference (P＜0.01) at the cure rate aspect treatment erythema, seborrhea, pruritus, the skin lesion area; Compare and all have utmost point significant difference (P＜0.01) at the cure-remarkable-effectiveness rate and the effective percentage of treatment aspect above-mentioned all symptoms.

Statistical analysis prompting: in medication during 4 weeks, cure rate, cure-remarkable-effectiveness rate, the effective percentage of the above-mentioned cardinal symptom of test group Drug therapy brawny tetter dermatitis all are significantly higher than the matched group medicine, illustrate that the test group medicine all obviously is better than matched group at the curative effect of each cardinal symptom.(table 9, shown in Figure 9)

As shown in figure 10: the test group medicine has been obtained curative effect preferably in 2 weeks of medication and medication 4 Zhou Shijun, and drug effect stable rising in the process of whole medication.

As shown in figure 11: the matched group medicine has been obtained curative effect preferably in 2 weeks of medication and medication 4 Zhou Shijun, and the drug effect performance is more stable.

Four, brawny tetter dermatitis chlosma is checked the statistics of situation

The comparison of (one) two group of each time point chlosma microscopy distribution of results of treatment front and back

Each time point chlosma microscopy distribution of results compares (example) (%) before and after the table 10 liang group treatment

Method: x ²Check

Statistical analysis:

Chlosma microscopy distribution of results there was no significant difference (P〉0.05) before two groups of treatments has comparability; Two arrangements of mirrors inspection distribution of results has significant difference (P＜0.05) when treating for 2 weeks; 4 whens week of treatment and drug withdrawal are during 4 weeks, and two arrangements of mirrors inspection distribution of results all has utmost point significant difference (P＜0.01).

The statistical analysis prompting: the microscopy distribution of results of two groups of preceding chlosmas of treatment is basic identical; Treatment back and drug withdrawal are during 4 weeks, and the microscopy distribution of results of two groups of chlosmas is all different.(as table 10, shown in Figure 12)

Shown in Figure 12: two groups of treatment 2 week back chlosma microscopy results are mainly the positive (+), treatment during 4 weeks the microscopy result be mainly feminine gender (-) and positive (+), drug withdrawal during 4 weeks the microscopy distribution of results remain on medication 4 substantially when all.Show that two groups of medicines all have certain bacteriostasis, and bacteriostasis continues still during 4 weeks to exist in drug withdrawal.(2) comparison of two groups of medicine fungistatic effects of treatment each time point of back

The comparison (example) of two groups of medicine fungistatic effects of table 11 treatment each time point of back

Annotate: turning out cloudy refers to transfer feminine gender to by strong positive, the positive, and taking a turn for the better refers to transfer the positive to by strong positive; Negative conversion rate=routine the number of turning out cloudy/total routine number; Effective percentage=(the routine number of turning out cloudy+routine number takes a turn for the better)/total routine number; Statistical method: x ²Check; Compare with matched group: * * P＜0.01, * P＜0.05, △ P 0.05

Statistical analysis:

Treatment 2 whens week, two groups of chlosma microscopies negative conversion rate are as a result compared there was no significant difference (P〉0.05), and effective percentage has been compared significant difference (P＜0.05); 4 whens week of treatment and drug withdrawal during 4 weeks two groups of chlosma microscopies negative conversion rate and effective percentage are compared and are all had utmost point significant difference (P＜0.01) as a result.

Statistical analysis prompting: the test group medicine is strong than the effect of matched group medicine in the bacteriostasis of medication during 2 weeks, this advantage continue 2 weeks of medication be medication during 4 weeks performance more obvious, and be maintained until drug withdrawal during 4 weeks.Aspect the fungistatic effect of brawny tetter dermatitis, two groups of medicines all show stable and bacteriostasis that continue due to the treatment chlosma, and the test group drug effect significantly is better than the matched group medicine.(shown in table 11, Figure 13,14)

Five, the statistics of brawny tetter dermatitis comprehensive therapeutic effect evaluation

The comparison (example) of comprehensive therapeutic effect when table 12 liang 2 weeks of group treatment and 4 weeks

Annotate: the cure rate=routine number of fully recovering/total routine number; Cure-remarkable-effectiveness rate=(the routine number of fully recovering+produce effects example number)/total routine number; Total effective rate=(the routine number of fully recovering+produce effects example number+effective routine number)/total routine number; Method: x ²Check; Compare with matched group: * * P＜0.01, △ P 0.05

Statistical analysis:

Treat the brawny tetter dermatitis during 2 weeks, and two groups cure rate comparison there was no significant difference (P〉0.05), cure-remarkable-effectiveness rate and total effective rate are compared all has utmost point significant difference (P＜0.01); Two groups cure rate, cure-remarkable-effectiveness rate and total effective rate are compared and are all had utmost point significant difference (P＜0.01) when treating for 4 weeks.

The statistical analysis prompting: the medication of treatment brawny tetter dermatitis is during 2 weeks, and the total effective rate of test group medicine has reached 75.24%, and the total effective rate of matched group medicine is 58.10%, and the general curative effect of test group medicine significantly is better than the matched group medicine; Continue medication during 2 weeks, the total effective rate of two groups of medicines continues to raise, reach 85.71% and 65.71% respectively, show that the drug effect performance is more stable in the medication process, overall symptom be improved significantly and alleviate, two groups of Drug therapy brawny tetter dermatitis all have certain effect, the matched group medicine that is higher than evident in efficacy of test group medicine.(shown in table 12, Figure 15,16)

Six, the statistics of the less important clinical symptoms of brawny tetter dermatitis

Table 13 is treated statistics (example) preceding and treatment less important clinical symptoms during 4 weeks

As shown in table 13: insomnia and irritated symptom have also obtained obvious improvement in the less important simultaneous phenomenon after 4 weeks of treatment.Seven, the statistics of others

(1) statistics of recurrence situation

The oestrus statistics (example) of condition of table 14 liang group drug withdrawal 4 all recurrence of disease at the same time next year

Statistical analysis: through x ²Check, two groups drug withdrawal 4 during week relapse rate compare there was no significant difference (P〉0.05).The statistics of (two) safety observed case

1. the statistics of hematuria regular situation before and after treating

Table 15 is treated statistics (example) preceding and treatment hematuria regular situation during 4 weeks

As shown in Table 15: two groups of patients' hematuria routine examination result does not see significant change with medication during 4 weeks before medication.

2. untoward reaction situation

In the process of whole clinical observation, 2 routine untoward reaction incidents appear in test group altogether, and 3 routine untoward reaction incidents appear in matched group altogether.See following table for details:

Table 16 untoward reaction situation statistics (example)

(3) pick out and the statistics of the case that comes off

Begin to end from clinical observation, have 10 patients and pick out and come off, see following table for details:

Table 17 is picked out and the statistics (example) of the case that comes off

(4) other situation statistics

Other situation statistics (example) of table 18

Experimentation

One, material

(1) test medication

Get Cortex Pseudolaricis, Radix Sophorae Flavescentis, Flos Caryophylli, Cortex Cinnamomi and Cacumen Platycladi raw material of Chinese medicine weight portion respectively, and be prepared into dry extract respectively, wherein Cortex Pseudolaricis, Radix Sophorae Flavescentis, Flos Caryophylli and four kinds of Chinese medical concrete adding distil waters of Cortex Cinnamomi are made suspension 10mL, and concentration is the test medication of 0.1g/mL; Cacumen Platycladi extractum adding distil water is made suspension 10mL, and concentration is 0.2g/mL test medication, deposits standby for 4 ℃.

The ketoconazole powder: produce by Xian-Janssen Pharmaceutical Ltd., content 99.9%, batch number: PUE561 is dissolved in 2.5% dimethyl sulfoxide (MDSO) solution, and control MDS0 final concentration is lower than 1%, and ketoconazole concentration is 1mg/mL.

(2) test strain

Test is provided by Beijing Medical University's fungus laboratory with two strain Malassezia furfur reference cultures (CBS1878).

(3) key instrument

1. drug sensitive test

Than turbid instrument, high-pressure sterilizing pot (SANYO MLS-3020), water bath (Beijing Medical Equipment Plant), constant temperature incubator (XMT-152C, Sida Experiment Instrument Factory, Chongqing), super-clean bench (making prosperous business corporation), microscope (OLYMPUS-BX6 0F5), blood cell counting plate (five metals optical instrument factory, Yuhuan county), disposable teat glass (diameter 20mm, Yangzhou Hanjiang innovation medical apparatus and instruments factory), electronic balance (Longteng Electronic Weighing Instrument Co., Ltd., Shenyang), double layer iron sheet electric furnace (Wuding County, Shanghai electrical apparatus factory, 220 volts 1200 watts on CL-A type), ELISA Plate at the bottom of 8 * 12 hole circles (chemical plant, BeiJing, China).

2. scanning electron microscope test

JEOL JSM-T300SCANNING MICROSCOPE (30 kilovolts of the highest accelerating potentials, 200,000 times of theoretical amplifications, resolution 60 nanometers)

(4) culture medium

1. olive oil solid medium

(1) raw material: glucose 20g (Shantou City's brilliance laboratory, lot number 990213, specification is the 500g/ bottle), agar 17g (Qingdao aquatic product manufactory, lot number 990330, specification are the 100g/ bottle), peptone 10g (Nat'l Pharmaceutical ﹠ Biological Products Control Institute, lot number 990206, specification is the 250g/ bottle), yeast extract 10g (UNIPATH LTD, ENGLAND, the 500g/ bottle), olive oil 20g (the sharp Food Co., Ltd of Beijing's product), chloromycetin 0.1g (Nanjing of China second pharmaceutical factory, lot number 980413, specification is the 250g/ bottle), distilled water 1000mL.

(2) method for making:

The first step: take by weighing above-mentioned raw materials and be dissolved in the distilled water, heated and boiled 3 times is fully dissolved mixed liquor and is the even translucent of terra-cotta;

Second step: autoclave sterilization 90 minutes (15 pounds, 121 ℃);

The 3rd step: treat that temperature drops to 4 ℃ of time-divisions and installs to test tube: in test tube, pour 5mL culture medium bevel (this step is operated) on super-clean bench;

The 4th step: it is standby to treat to put into 4 ℃ of refrigerators after the culture medium cooled and solidified.

2. chlosma fluid medium

(1) raw material: maltose 20g, yeast extract 2g, glucose 20g, olive oil 20g, distilled water 500mL.

(2) method for making:

The first step: take by weighing the above-mentioned raw materials uniform dissolution in distilled water;

Second step: autoclave sterilization 90 minutes (15 pounds, 121 ℃);

The 3rd step: it is standby to treat to put into when temperature drops to room temperature 4 ℃ of refrigerators.

Two, method

(1) drug sensitive test

With reference to yeast micro-dilution method in the M27-A scheme of standardization committee of American National clinical laboratory (NCCLS) formulation, improve on this basis, adopt the liquid base of butyraceous culture medium as drug sensitive test, chlosma is carried out external drug sensitive test.For reduce test error as far as possible, the bacteriostatic test of every kind of medicine repeats 10 times under same test conditions, and the result gets average.Divide two parts to carry out: 1, single medicinal material drug sensitive test research; 2, herbal mixture drug sensitive test research (compound recipe is five kinds of mixed liquors that single medicinal material makes up with same concentrations).The ketoconazole solution of while and 1mg/mL carries out the fungistatic effect contrast.

1. medicinal liquid application of sample

(1) the Chinese medicine stock solution directly is diluted to experimental concentration with the chlosma fluid medium, contains medicinal liquid 100%, 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% respectively; Ketoconazole solution also is diluted to experimental concentration with the chlosma fluid medium, contains medicinal liquid 100%, 50%, 25%, 12.5%, 6.25%, 3.125%, 1.5625%, 0.78125%, 0.39063%, 0.19531% respectively;

(2) medicinal liquid after will diluting adds Microdilution plate (ELISA Plate at the bottom of 96 hole circles), every hole 100 μ L;

(3) every kind of medicine is done 2 groups simultaneously.

2. bacteria suspension preparation

(1) with standard pityrosporum furfur inoculation on the olive oil solid medium, 37 ℃ of constant temperature incubators were cultivated 4 days;

(2) with physiological saline solution eluting bacterium colony, make bacteria suspension;

(3) use than turbid instrument adjust its to the Maxwell No. 4 opacity tube concentration;

(4) count its bacterial content with blood cell counting plate, and transfer its concentration to be (1.0-2.0) * 10 ⁷CFU/mL;

(5) the bacterium liquid of usefulness chlosma fluid medium dilution previous step gained is 10 times, makes its bacterial content be (1.0-2.0) * 10 ⁶CFU/mL;

(6) get pastille 96 orifice plates that prepare, every hole adds the bacterium liquid 100 μ L of previous step in the pastille microwell plate, makes its final bacteria concentration be (0.5-1.0) * 10 ⁶CFU/mL, the final concentration of each traditional Chinese medicine liquid is respectively 50mg/mL, 45mg/mL, 40mg/mL, 35mg/mL, 30mg/mL, 25mg/mL, 20mg/mL, 15mg/mL, 10mg/mL, 5mg/mL; The final concentration of ketoconazole medicinal liquid is respectively 500 μ g/mL, 250 μ g/mL, 125 μ g/mL, 62.5 μ g/mL, 31.25 μ g/mL, 15.625 μ g/mL, 7.8125 μ g/mL, 3.9063 μ g/mL, 1.9531 μ g/mL, 0.9766 μ g/mL.Establish one group of negative control simultaneously: every hole adds chlosma fluid medium 200 μ L; One group of positive control: every hole adds bacterium liquid 100 μ L and the chlosma fluid medium 100 μ L that prepare.

(7) on shaking table with bacterium liquid and medicinal liquid mixing 5min.

3. interpretation as a result and statistics

The well plates that inoculation is good is put 37 ℃ of incubations, and observed result behind the 48h is because chlosma is to have a liking for fat, bacterium colony floats over liquid surface, little yellow, and very thin one deck swims in transparent liquid primary surface, perusal is very clear, adopts direct method to read data.The prerequisite that the result judges is the positive control well-grown, and the negative control asepsis growth is clear, and the growth of bacterium is suppressed with the rising of drug level gradient in other hole.If there is conditions of streaking, then growing state and positive control in every hole are compared, be suppressed 80% with growth and be judged to be the MIC value.The record test data is also analyzed.

(2) Electronic Speculum test

1. the preliminary preparation of specimen

(1) coverslip is cut into about 1 * 1cm ²The size several pieces, the sign positive and negative;

(2) with above-mentioned little slide with the preliminary cleaning of distilled water after, immerse to soak in the strong acid solution and pulled out in 48 hours, with distilled water the residual solution on the slide is rinsed well, dried naturally in the rearmounted gnotobasis in 24 hours with 95% soak with ethanol;

(3) will clean clean little slide and insert one by one in the fluid medium of having inoculated the standard pityrosporum furfur, cultivate 4～5 days in 37 ℃ of constant temperature incubators;

(4) choose the pityrosporum furfur slide preferably of growing, insert in the middle drug solns of variable concentrations and in 37 ℃ of constant temperature incubators, act on 8,24,48 hours respectively;

(above-mentioned the 3rd, 4 steps all operate in aseptic super-clean bench)

2. the fixing and dehydration (operating in the aseptic super-clean bench) of specimen

(1) preceding fixing: as to place 2.5% glutaraldehyde solution to fix more than 2 hours above-mentioned specimen, with 0.1%mmol phosphate buffer flushing three times (each flushing 10 minutes at interval);

(2) back is fixing: after 1% osmic acid is fixed 1 hour, with 0.1%mmol phosphate buffer flushing three times (each flushing 10 minutes at interval);

(3) dehydration: the ethanol with 30%, 50%, 70%, 90%, 100% concentration carries out gradient dehydration (100% concentration is strengthened twice) respectively, each dehydration 10 minutes at interval;

(4) isoamyl acetate displacement ethanol was used dry 1 minute of hexamethyl ammonia nitrogen alkane after 20 minutes, glued platform after waiting to volatilize, ion sputtering instrument spraying plating, gold-plated.

3. the result observes

The specimen for preparing is placed observation under the JEOL JSM-T300 scanning electron microscope.

The result

One, external drug sensitive test

The drug sensitive test of the mixed liquor of each single medicinal material and same concentrations various combination has all repeated under same test conditions 10 times, records MIC value (being converted into crude drug concentration) respectively, and it is as follows to get after the average statistics: (shown in table 18～table 23)

The MIC average of each single medicinal material of table 18

Annotate: mixed liquor 2-1: Cortex Pseudolaricis+Cacumen Platycladi; Mixed liquor 2-2: Cortex Pseudolaricis+Radix Sophorae Flavescentis; Mixed liquor 2-3: Cortex Pseudolaricis+Flos Caryophylli; Mixed liquor 2-4: Cortex Pseudolaricis+Cortex Cinnamomi; Mixed liquor 2-5: Cacumen Platycladi+Radix Sophorae Flavescentis.

The MIC average (two) of each mixed liquor of table 20

Annotate: mixed liquor 2-6: Cacumen Platycladi+Flos Caryophylli; Mixed liquor 2-7: Cacumen Platycladi+Cortex Cinnamomi; Mixed liquor 2-8: Radix Sophorae Flavescentis+Flos Caryophylli; Mixed liquor 2-9: Radix Sophorae Flavescentis+Cortex Cinnamomi; Mixed liquor 2-10: Flos Caryophylli+Cortex Cinnamomi.

The MIC average (three) of each mixed liquor of table 21

Annotate: mixed liquor 3-1: Cortex Pseudolaricis+Cacumen Platycladi+Radix Sophorae Flavescentis; Mixed liquor 3-2: Cortex Pseudolaricis+Cacumen Platycladi+Flos Caryophylli; Mixed liquor 33: Cortex Pseudolaricis+Cacumen Platycladi+Cortex Cinnamomi; Mixed liquor 3-4: Cacumen Platycladi+Radix Sophorae Flavescentis+Flos Caryophylli; Mixed liquor 3-5: Cacumen Platycladi+Radix Sophorae Flavescentis+Cortex Cinnamomi.

The MIC average (four) of each mixed liquor of table 22

Annotate: mixed liquor 3-6: Radix Sophorae Flavescentis+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 3-7: Cortex Pseudolaricis+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 3-8: Cacumen Platycladi+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 3-9: Cortex Pseudolaricis+Radix Sophorae Flavescentis+Flos Caryophylli; Mixed liquor 3-10: Cortex Pseudolaricis+Radix Sophorae Flavescentis+Cortex Cinnamomi.

The MIC average (five) of each mixed liquor of table 23

Annotate: mixed liquor 4-1: Cortex Pseudolaricis+Cacumen Platycladi+Radix Sophorae Flavescentis+Flos Caryophylli; Mixed liquor 4-2: Cacumen Platycladi+Radix Sophorae Flavescentis+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 4-3: Cortex Pseudolaricis+Radix Sophorae Flavescentis+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 4-4: Cortex Pseudolaricis+Cacumen Platycladi+Radix Sophorae Flavescentis+Cortex Cinnamomi; Mixed liquor 4-5: Cortex Pseudolaricis+Cacumen Platycladi+Flos Caryophylli+Cortex Cinnamomi; Mixed liquor 5: Cortex Pseudolaricis+Cacumen Platycladi+Radix Sophorae Flavescentis+Flos Caryophylli+Cortex Cinnamomi.

Shown in table 18～table 23: each single medicinal material and mixed liquor all show the effect of certain inhibition chlosma growth in drug sensitive test.In the single medicinal material, the bacteriostasis of Cortex Pseudolaricis the strongest (the MIC value is 10mg/mL) secondly is Flos Caryophylli, Cortex Cinnamomi and Radix Sophorae Flavescentis, the bacteriostasis of Cacumen Platycladi the most weak (the MIC value is 45mg/mL); In five kinds of single medicinal material mixed liquors, the effect of mixed liquor 5 the strongest (the MIC value is 5.5mg/mL), next is mixed liquor 3-1 (the MIC value is 8.5mg/mL), mixed liquor 2-10 (the MIC value is 9mg/mL), mixed liquor 2-8 (the MIC value is 10.5mg/mL), the MIC value of all the other mixed liquors between the 31mg/mL, all has the effect that suppresses the chlosma growth at 12mg/mL.To sum up, five kinds of isocyatic mixed liquors of single medicinal material (mixed liquor 5) and each single medicinal material and other blended liquid phase are than bacteriostasis all strong (as shown in figure 17); The bacteriostasis of ketoconazole solution is apparent in view, and the MIC value is 6.64 μ g/mL, significantly is lower than the MIC value of each single medicinal material and Chinese medicine mixed liquor.

Two, scanning electron microscope test

Observed result under the mirror of chlosma during (one) without drug effect

Form under the mirror of chlosma during without drug effect: can clearly observe the circular or oval-shaped thallospore that goes out, promptly the end at spore has papillae, around projection, there is a ring-type neck ring spline structure to hold, projection enlarges the back and forms little spore, the position that links to each other with sporont neck ring spline structure forms the handle (bud neck) of constriction, like dumbbell shaped.Spore is abundanter, and cell wall structures is complete, and the thalline surface is more plentiful, does not see depression and shrinkage.(as Figure 18～shown in Figure 21)

(2) Chinese medicine mixed liquor 5 (concentration is 5.5mg/mL) acts on observed result under the mirror of chlosma after 8 hours, 24 hours, 48 hours respectively

Chlosma is form under the mirror of Chinese medicine mixed liquor 5 (concentration is 5.5mg/mL) effect after 8 hours: the cell wall uneven distribution, and shrinkage and depression appear in the thalline surface, a small amount of spore fragmentation; Act on form under the mirror after 24 hours: the bud neck structure of parton spore and sporont junction is damaged and ruptures, and zygoblast separates with sporont, and protein part overflows in the endochylema, the obvious attenuation of cell wall, depression or disappearance to the inside; Act on form under the mirror after 48 hours: endochylema is excessive, somatic cells fragmentation, death, and the albumen sample of visible a large amount of fragments and high electron density solidifies the shape material.(as Figure 22～shown in Figure 30)

The scanning electron microscope results suggest: Chinese medicine mixed liquor 5 (concentration is 5.5mg/mL) acts on chlosma respectively after 8 hours, 24 hours, 48 hours, ultrastructure presents the seriality of spore and destroys performance, has illustrated that from microcosmic angle medicine of the present invention has antibacterial or germ-resistant effect to chlosma.

Claims

One kind the prevention and the treatment seborrheic dermatitis Chinese medicine composition, it is characterized in that described Chinese medicine composition is made by following weight parts proportion raw material medicine:

Cortex Pseudolaricis 20～50 weight portions, Radix Sophorae Flavescentis 25～45 weight portions, Flos Caryophylli 10～20 weight portions, Cortex Cinnamomi 10～20 weight portions, Cacumen Platycladi 30～60 weight portions.
2. the Chinese medicine composition of prevention according to claim 1 and treatment seborrheic dermatitis is characterized in that described Chinese medicine composition is made by following weight parts proportion raw material medicine:

Cortex Pseudolaricis 30～40 weight portions, Radix Sophorae Flavescentis 35～45 weight portions, Flos Caryophylli 9～14 weight portions, Cortex Cinnamomi 11～16 weight portions, Cacumen Platycladi 40～50 weight portions.
3. a Chinese medicine preparation that prevents and treat seborrheic dermatitis is characterized in that described Chinese medicine preparation is made by acceptable auxiliary on claim 1 or 2 described Chinese medicine compositions and the pharmaceutics.
4. the Chinese medicine preparation of prevention according to claim 3 and treatment seborrheic dermatitis is characterized in that described dosage form is an exterior-applied formulation.
5. the Chinese medicine preparation of prevention according to claim 4 and treatment seborrheic dermatitis, it is characterized in that described exterior-applied formulation is shampoo, hair cream, cleansing milk and the body lotion of external hair washing preparation, spray, externally used paste, fumigation and wash method preparation and prevention and health care type.
6. the preparation method of the Chinese medicine composition of described prevention of claim 1 and treatment seborrheic dermatitis is characterized in that its concrete preparation process is as follows:

(1) by the weight portion proportioning weighting raw materials of claim 1 or 2 described each crude drug, standby;

(2) each flavor crude drug mixing and water adding is decocted three times.Add for the first time the water of 8～12 times of weight, seethed with excitement 2～3 hours; Add for the second time the water of 6～8 times of weight, seethed with excitement 1～2 hour; The water that adds 4～6 times of weight for the third time seethed with excitement 0.5～1 hour; Merge three times decoction liquor, filter, remove wherein impurity;

(3) with filtrate at vacuum 1.33Kpa, under 40～50 ℃ of environment, be condensed into relative density and be 1.2～1.3 extractum;

(4) utilize spray drying process to make dry extract, promptly make active drug component of the present invention.
7. the preparation method of the Chinese medicine composition of prevention according to claim 6 and treatment seborrheic dermatitis is characterized in that, comprises that also step (5) is added to mixing in the hair washing substrate with the active drug component, promptly makes the hair washing preparation.
8. the preparation method of the Chinese medicine composition of prevention according to claim 7 and treatment seborrheic dermatitis is characterized in that, the w/v of described active drug component and hair washing substrate is 6～8:100.